Use of Caffeine to Reduce Length of Mechanical Ventilation in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Age at First Successful Extubation
研究概览
简要总结
Most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop Bronchopulmonary Dysplasia (BPD). Caffeine is a stimulant of the respiratory center and has been used for the treatment of Apnea of Prematurity in infants not requiring mechanical ventilation or to facilitate weaning from mechanical ventilation by starting therapy shortly before extubation. Recently the use of Caffeine in ventilated infants has been initiated earlier because of the reported reduction in BPD. However there is paucity of data supporting this practice.
Because protracted mechanical ventilation and supplemental oxygen increase the risk of developing BPD, a therapy that would facilitate the reduction of the respiratory support and shorten its duration is desirable. Therefore, it is of importance to evaluate the effects of early Caffeine initiation and administration during the course of mechanical ventilation in preterm infants by means of a randomized placebo-controlled trial.
Hypothesis:
The primary hypothesis of this study is that early use of caffeine in mechanically ventilated preterm infants will reduce the time to first elective extubation and secondarily, that this will reduce the total duration of mechanical ventilation and oxygen supplementation, and reduce the incidence and severity of BPD.
Objective:
The objective of this trial is to evaluate the effects of early caffeine use during mechanical ventilation on the time to first elective extubation, total duration of mechanical ventilation and oxygen supplementation, and the incidence of BPD.
Study Design:
This will be a single-center prospective, randomized, double-blind, placebo controlled clinical trial.
Population:
Premature neonates born between 23 and 30 completed weeks of gestation, who require mechanical ventilation within the first 5 days of life will be enrolled. Infants with major congenital anomalies or small for gestational age will be excluded.
Methods:
Infants will be randomized within the first 5 days to receive a study drug consisting of either blinded Caffeine citrate or blinded Placebo (equivalent volume of normal saline). Infants will continue to receive the study drug until the first elective extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature neonates born between 23 and 30 completed weeks of gestation.
- •Requiring mechanical ventilation within the first 5 postnatal days
- •Written-informed parental consent for the study
排除标准
- •Major congenital anomalies
- •Small for gestational age
研究组 & 干预措施
Caffeine Arm
Subjects randomized to this arm will receive blinded Caffeine citrate.
干预措施: Caffeine citrate (Drug)
Placebo Arm
Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
干预措施: Normal saline (Other)
结局指标
主要结局
Age at First Successful Extubation
时间窗: From birth to until 36 weeks postmenstrual age
Defined as age of extubation with infant remaining extubated for more than 24 hours.
次要结局
- Total Duration of Mechanical Ventilation(From the time of first intubation until the last extubation, up to 36 weeks corrected age)
- Total Duration of Oxygen Supplementation(From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age)
- Number of Infants With Bronchopulmonary Dysplasia (BPD)(Evaluated at 36 weeks corrected postmenstrual age)
- Survival Without BPD(From the time of randomization until 36 weeks corrected age, discharge or death)
- Survival(From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death)
研究者
Eduardo Bancalari
Professor
University of Miami